NICE turns down earlier use of Eisai’s Halaven

Cost regulators for NHS treatments in England and Wales have rejected funding for Eisai’s Halaven as a second-line of attack against a certain form of breast cancer.

In draft guidelines, the National Institute for Health and Care Excellence said the drug was too expensive for use in patients locally advanced or secondary breast cancer in adults who have had only one chemotherapy regimen.

Halaven (eribulin) increases overall survival by an average of 4.6 months compared with capecitabine, but it doesn’t increase the time during which the tumour doesn’t grow, it said.

It is not clear whether the overall survival boost is because of Halaven alone or because of effective treatments given after the drug, and there are no clinical trials assessing the effect of different sequences, the Institute noted.

As such, the Committee concluded that the most likely cost effectiveness estimate for Halaven would fall at the top end of the estimated range of £36,244 to £82,743 per quality-adjusted life year, and thus outside of what is normally considered acceptable for end-of-life treatments.

“That eribulin cannot offer women with metastatic breast cancer a new second-line therapy option is very disappointing news, particularly for patients with ‘triple negative’ breast cancer, who – despite recent advances for other subtypes of the disease – still have very few treatment options,” said Samantha Nicklin, Assistant Director of Policy and Campaigns at Breast Cancer Now.

Halaven, which belongs to a class of antineoplastic agents, the halichondrins, that are derived from the marine sponge Halichondria okadai, was first approved for breast cancer in the US in 2010 and in the EU in 2011, and also won FDA clearance for liposarcoma back in January.

The drug is already funded by the NHS for breast cancer patients who have had two prior chemotherapy regimens.